San Francisco Bay Area
Global Pharma Technical Operations (PTT), Strategy Realization Office (SRO)
- Lead Engineer for a team composed of Automation, Facilities, IT Validation, and Equipment Validation engineers, providing Engineering expertise on sitewide projects, change requests, and facility coordination for commissioning and qualification - Involved in resource planning and test scheduling for the Engineering and Validation team - Supervised contract support and junior engineers on document creation, equipment installation and calibration, test execution, and prioritization of tasks and deadlines, in addition to mentoring and developing their skills in validation strategy (risk-based, family approach, bracketing, automation functional testing, etc.) and increasing their overall quality mindset
- Led teams of Validation Engineers and contractors on protocol generation, testing strategy, deviation assessment, data analysis, and GMP release. During test executions, ensured the teams were set up for success by providing timely and thorough communication regarding schedule, preparation activities, testing objectives, point-of-contacts for as-needed support, and answered texts and calls quickly to ensure support was given at all hours of testing - Generated and maintained lifecycle and non-lifecycle documentation, such as System Impact Assessments, User Requirements Specifications, Criticality Assessments, Risk Assessments, Qualification Project Plans, Requirements Trace Matrices, DQ/IQ/OQ/PQ protocols and reports - Successfully defended qualification packages in internal and regulatory audits, including to the FDA - Collaborated cross-functionally during design and implementation of new systems or modification of existing systems, including participating in design reviews, developing qualification strategies, maintaining lifecycle documents, executing testing, and analyzing/summarizing test results
- Knowledge of cGMP, cGDP, risk-based qualification strategy, ASTM E2500, data integrity, computer system validation, GAMP categorization - Led equipment qualification and computer system validation activities on analytical systems and automated equipment, such as Analyzers, Upstream Manufacturing Systems (Cell Culture and Fermentation), and Downstream Manufacturing Systems (Recovery and Purification)
- Have experience in operating and qualifying upstream cell culture and downstream protein purification systems for both clinical and commercial manufacturing - Have authored, facilitated, and executed material risk assessments, equipment FMEAs or system impact assessments, validation IQ/OQ/PQ/PPQ protocols, deviation/discrepancy resolutions, and validation final reports